Article | March 25, 2019

The Top 5 Questions To Ask When Developing A REMS

Source: United BioSource LLC (UBC)

By Natalie O’Donnell, Executive Director, Safety, Epidemiology, Registries & Risk Management, UBC


A REMS should be considered when risk mitigation efforts are required beyond product labeling and routine pharmacovigilance. This article answers the following questions regarding REMS

  • How do you determine if a REMS is needed during product development?
  • Who from your organization needs to be at the REMS design table?
  • How do you align the products commercial strategy with the REMS?
  • What are the appropriate metrics to assess your REMS?
  • Can you implement a REMS in your organization or should you plan to outsource?